Pronestyl (Procainamide Hydrochloride) - Summary

PRONESTYL SUMMARY

PRONESTYL^® TABLETS
Procainamide Hydrochloride Tablets USP

PRONESTYL^® CAPSULES
Procainamide Hydrochloride Capsules USP

PRONESTYL (procainamide hydrochloride), a Group 1A cardiac antiarrhythmic drug, is p-amino-N-{2-(diethylamino)ethyl}-benzamide monohydrochloride, molecular weight 271.

PRONESTYL (procainamide hydrochloride) is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of PRONESTYL, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.

Initiation of PRONESTYL treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.

Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (See WARNINGS and Boxed WARNING.)

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NEWS HIGHLIGHTS

Published Studies Related to Pronestyl (Procainamide)

Levofloxacin and ciprofloxacin decrease procainamide and N-acetylprocainamide renal clearances. [2005.04]
Ten healthy adults participated in a randomized, crossover drug interaction study testing procainamide only, procainamide plus levofloxacin, and procainamide plus ciprofloxacin.

Effects of procainamide and sotalol on restitution properties, dispersion of refractoriness, and ventricular fibrillation activation patterns in pigs. [2008.10]
BACKGROUND: Interest in combining antiarrhythmic drugs has been prompted by the lack of efficacy of monotherapies and the toxicity resulting from high doses of individual agents. OBJECTIVES: We tested the hypothesis that procainamide and sotalol combined have greater beneficial effects on restitution, on the dispersion of refractoriness, and on decreasing the complexity of ventricular fibrillation (VF) than either drug alone... CONCLUSIONS: Procainamide and sotalol combined have greater beneficial effects on restitution properties, dispersion of refractoriness, and the complexity of VF than either drug alone compared with baseline.

Emergency department use of intravenous procainamide for patients with acute atrial fibrillation or flutter. [2007.12]
OBJECTIVES: Acute atrial fibrillation and flutter are very common arrhythmias seen in emergency department (ED) patients, but there is no consensus for their optimal management. The objective of this study was to examine the efficacy and safety of intravenous (IV) procainamide for acute atrial fibrillation or flutter... CONCLUSIONS: This study of acute atrial fibrillation or flutter patients treated in the ED with IV procainamide suggests that this treatment is safe and effective in this setting. Procainamide should be prospectively compared with other ED strategies.

Comparative study of intravenous amiodarone and procainamide in the treatment of atrial fibrillation of recent onset. [2007.08]
AIM: The aim of the present study was to compare the safety and efficacy of amiodarone and procainamide in the acute cardiology setting... CONCLUSION: Both drugs were equally effective in restoring SR, though procainamide acts quicker in the loading phase. Both medications are safe and side effects develop only in the maintenance phase.

A comparative study of the efficacy and safety of procainamide versus propafenone versus amiodarone for the conversion of recent-onset atrial fibrillation. [2007.06.15]
The appropriate treatment for the restoration of sinus rhythm in patients with atrial fibrillation (AF) of recent onset is still the subject of controversy. In this prospective, randomized, single-blind, placebo-controlled clinical study, we investigated the effectiveness and safety of procainamide, propafenone, and amiodarone, administered intravenously, for the conversion of recent-onset AF...

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Clinical Trials Related to Pronestyl (Procainamide)

Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia [Recruiting]
The purpose of this study is to determine whether intravenous amiodarone has less cardiac significant adverse events compared to intravenous procainamide in the acute treatment of haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably ventricular origen.

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias [Recruiting]
The study evaluates 3 different populations:

It is an open, randomized, parallel-group study comparing the effectiveness of intravenous (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :

1. recent-onset atrial fibrillation versus iv flecainide

2. sustained monomorphous ventricular tachycardia versus iv procainamide

The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of Brugada syndrome

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) [Completed]
To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.

Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) [Completed]
To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better method for selecting effective long-term antiarrhythmic drug therapy in patients with sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden death.

Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) [Completed]
To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.

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